EPA has finalized its Toxic Substances Control Act (“TSCA”) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substance (“PFAS”) rule. The rule offers none of the customary TSCA reporting exemptions, such as the di minimus threshold exemption, article exemption, and research and development exemption. Although industry members voiced significant concerns over the proposed rule, the scope of the rule remains expansive. A summary of the final rule is detailed below.
Who does the final rule apply to?
40 CFR § 705.10 identifies the entities that are covered under the rule. The rule, which Congress mandated through the FY2020 National Defense Authorization Act, applies to all entities that have manufactured and/or imported a PFAS for commercial purposes, including those present in a mixture and in an article since January 1, 2011. Those who have only processed, distributed in commerce, used, and/or disposed of PFAS are not subject to this rule.
Which PFAS must be reported under the final rule?
EPA has identified PFAS subject to the rule by a structural definition rather than a list of substance identities (40 CFR § 705.5). However, EPA will provide a public list of substances that meet this definition on its CompTox Chemical Dashboard. The definition of PFAS using a structural definition is as follows:
- R-(CF2)-CF(R’)R’’, where both the CF2 and CF moieties are saturated carbons;
- R-CF2OCF2-R’, where R and R’ can either be F, O, or saturated carbons; and
- CF3C(CF3)R’R’’, where R’ and R’’ can either be F or saturated carbons.
This differs from the proposed rule, which defined PFAS as “a substance that includes the following structure: R-(CF2)–C(F)(R′)R″, in which both the CF2 and CF moieties are saturated carbons and none of the R groups (R, R′ or R″) can be hydrogen.”
Reporting threshold
There is no reporting threshold or de minimis level for PFAS reporting. The traditional TSCA reporting exemptions, such as byproducts and impurities, and low volume exemptions, are not being upheld under this rule and require reporting.
Reporting standard
40 CFR § 705.15 states that the reporting standard that applies to this rule is information “known or reasonably ascertainable” by the manufacturer. This means “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know” (See 40 CFR 704.3). Under this standard, the manufacturer must evaluate not only their current level of knowledge regarding substances that are manufactured or imported, including those in articles, but also any additional information that a reasonable person, similarly situated, would be expected to know, possess, or control.
To obtain the necessary information for reporting, EPA expects the manufacturer/importer to conduct a reasonable inquiry into their own organization and potentially make inquiries outside the organization. According to the Agency, this may require “phone calls or email inquiries to upstream suppliers or downstream users or employers or other agents of the manufacturer, including persons involved in the research and development, import or production, or marketing of the PFAS.”
If data is unknown or not reasonably ascertainable, the submitter should, if possible, submit reasonable estimates. If manufacturers or importers need additional information for reporting, but suppliers are unwilling to provide that information, they can send a request for information through EPA’s reporting tool.
What information must be reported?
The scope of information required is vast. Data elements are detailed at 40 CFR §705.15 and include:
- Chemical-specific information for all PFAS manufactured each year since January 1, 2011, including PFAS incorporated in mixtures.
- Categories of use, including information on the sector, industrial processing, commercial and consumer use, and product categories.
- Concentrations of each PFAS used in consumer and commercial products.
- Manufactured amounts.
- Byproduct identification.
- Environmental and health effects data – which must be submitted according to OECD Harmonized Templates for Reporting Chemical Test Summaries.
- Worker exposure data.
- Disposal data.
Reporting on PFAS in Articles
Articles importers are subject to the reporting rule. The fact that there is no de minimis concentration threshold makes the scope of this mandate expansive. Because the known and reasonably ascertainable standard applies to this rule, importers must go beyond simply reviewing the SDSs for the imported articles. To demonstrate compliance with the rule, importers will need to survey their suppliers about the presence of PFAS in all of the articles they have imported since January 1, 2011. However, the rule does not mandate any product testing for article importers.
The rule does exempt some data elements from reporting for PFAS imported in articles, such as byproduct identification, worker exposure data, and disposal data.
R&D exemptions to the reporting requirements
Manufacturers and importers of R&D PFAS substances are subject to the reporting rule. The reporting requirements are reduced where volumes are below 10 kilograms annually.
Electronic reporting
All information must be submitted electronically through CDX (see 40 CFR § 705.35). A new tool, the Chemical Information Submission System (“CISS”), will be added to the CDX module “Submission for Chemical Safety and Pesticide Program” (“CSPP”). Reporting will be submitted through the CISS, which the Agency is currently developing, and will be live prior to the opening of the reporting period.
CBI claims
PFAS manufacturers reporting under this rule may claim CBI consistent with TSCA section 14, but they must make the CBI claim with their submission for this rule. CBI claims submitted for other reporting requirements will not be considered. See 40 CFR § 705.30 for details.
Reporting timeline
Manufacturers and importers will have one year from the effective date of this rule, November 13, 2023, to collect the data necessary for reporting and an additional six months to submit their reports; reports will be due May 13, 2023. Small manufacturers (as defined in 40 CFR 704.3) will have an additional six months to report, making their reporting deadline November 13, 2024.
Recordkeeping requirements
Manufacturers and importers subject to this rule must maintain records of all documents and information reported to EPA for five years, beginning on the last day of the information submission period.
Eight Circuit Vacates Chlorpyrifos Ban
/in FFDCA, FIFRA, News & Events, PesticidesEPA’s ban on the pesticide chlorpyrifos was arbitrary and capricious because the Agency failed to adequately consider other options, the Eighth Circuit Court of Appeals ruled on November 2, 2023, in the case Red River Valley Sugarbeet Growers Ass’n v. Regan.
EPA’s 2021 revocation of all chlorpyrifos tolerances was the result of a Ninth Circuit decision ordering EPA to either modify chlorpyrifos tolerances to ensure they are safe for children or revoke them entirely. EPA had previously determined that 11 “high-benefit” uses were likely to be safe if other uses were revoked. But with only 60 days to make a decision and under a court directive not to “engage in additional fact-finding,” EPA opted to revoke all tolerances, effectively banning use of chlorpyrifos on all food and animal feed.
The Eighth Circuit characterized EPA’s decision to revoke all tolerances, despite evidence that some uses could be considered safe, as “g[iving] up” in the face of a “tight deadline.” “EPA should not have reflexively rejected an approach it had the power to adopt, even if it would have required more work,” the court said.
Under the Federal Food, Drug, and Cosmetic Act, EPA can only leave in place tolerances that the Agency has determined to be safe after consideration of aggregate exposure, “including all anticipated dietary exposures.” In a 2022 order denying objections to the 2021 revocation, EPA argued that it would not be reasonable to consider exposures solely from the 11 high-benefit uses as “anticipated” because EPA did not have reason to believe they would reflect real-world exposures. EPA is required to determine whether tolerances are safe, not whether they will be safe “at some unspecified future time,” the Agency said.
The court rejected this interpretation of the statute, which was central to EPA’s decision not to implement a partial ban. The Agency has an “obligation to ‘anticipate[]’ the effects of its own actions,” Chief Judge Lavenski Smith wrote for the three-judge panel. If EPA proposed to “keep a set of high-benefit uses in place,” it could certainly “anticipate what would happen under its own proposal.”
The court vacated both the 2021 revocation and the 2022 denial order, remanding to EPA. The Agency will have 45 days from the date of the ruling to petition for rehearing or rehearing en banc.
More information on the legal battles over chlorpyrifos tolerances can be found in a previous Verdant Law blog post.
EPA to Consider Revising FIFRA Exemption for Pesticide-Treated Seeds and Paint
/in EPA, FIFRAOn October 12, 2023, EPA published an advance notice of proposed rulemaking on seeds (“treated seeds”) and paint (“treated paint”) treated with a pesticide that is registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (“treating pesticide”). Treated seeds and treated paints are currently exempted from FIFRA under the “treated articles and substances” exemption at 40 CFR 152.25(a) as long as their use is consistent with the treating pesticide’s label instructions.
EPA’s longstanding position has been that subjecting treated articles to FIFRA requirements would be unnecessary since the treating pesticide would have already been assessed during the pesticide registration process. This position was challenged in 2017 by the Center for Food Safety, which filed a petition requesting that EPA remove the exemption for treated seeds and aggressively enforce FIFRA’s pesticide labeling and registration requirements for seeds treated with systemic insecticide chemicals. EPA denied the petition in 2022 but acknowledged that the use of a treated seed contrary to the treating pesticide’s labeling instructions is generally not enforceable under FIFRA. As a result, EPA noted its intention to issue the current advance notice of proposed rulemaking to collect more information on treated seeds. EPA also included treated paints in the notice because of concerns that painters may be exposed to treated paint without adequate PPE.
The information specifically requested by the notice falls into five main categories:
EPA also requests comments on whether exposure to treated seeds and paint may be an environmental justice concern and comments regarding potential child health concerns. Comments on the notice will be accepted through December 11, 2023.
EPA Proposes Changes to TSCA Risk Evaluation Procedures
/in EPA, Risk Evaluations & Management, TSCAOn October 30, 2023, EPA published a proposed rule altering the procedures for chemical risk evaluations under section 6 of the Toxic Substances Control Act (TSCA). The proposed rule revises the existing 2017 framework, which was adopted one year after Congress passed amendments to TSCA requiring EPA to evaluate whether existing chemicals that have been identified as “high priority” present an unreasonable risk of injury to health or the environment.
The rulemaking includes the following proposed changes:
The above changes would apply to all risk evaluations initiated on or after the date of the final rule. For risk evaluations in progress on the date of the final rule, EPA expects to apply the changes “only to the extent practicable.”
The proposed clarification that EPA includes all conditions of use in the scope of a risk evaluation stems from the Ninth Circuit’s 2019 decision in Safer Chemicals, Healthy Families v. EPA. In the case, petitioners successfully challenged EPA’s exclusion of “legacy uses and associated disposals”—such as the use and future disposal of asbestos in previously installed insulation—from the scope of risk evaluations. Several of the other proposed changes would codify existing EPA practices introduced in 2021, including the requirement that risk evaluations end with a single determination rather than use-by-use determinations.
EPA requests public comments on all aspects of the proposed rulemaking. Comments are due on December 14, 2023.
California to Require Substantiation of Carbon Neutral Claims
/in California, Green Marketing, TransparencyUnder a new California law enacted on October 7, 2023, companies selling carbon offsets or making carbon-neutral claims must now provide evidence to substantiate these measures and claims.
The law requires that businesses marketing carbon offsets disclose specific information on their websites. This includes details on how emissions reductions were estimated, data and calculation methods to verify these estimates, whether there is third-party oversight, and the accountability measures in place if the project is not completed or proves to be less effective than advertised. Companies that buy offsets will be required to provide an overview of each offset, including the business that sold the offset, on their websites.
In addition, the measure requires companies that claim to be carbon neutral or claim that they have made significant emissions reductions to support their claims with all available evidence. Companies must also disclose whether there is third-party oversight of their claims or supporting data.
The law, which is reportedly the first of its kind in the US, authorizes fines of up to $500,000 per violation. In a press release, the law’s author characterized the legislation as providing necessary transparency amid concerns about corporate greenwashing and the effectiveness of many carbon offsets.
Irene Hantman Presents on EPA’s Audit Policy and TSCA Audits at PSX 2023
/in News & Events, TSCAVerdant Law is pleased to report that Irene Hantman gave a presentation on EPA’s Audit Policy and Toxic Substances Control Act (TSCA) audits on October 18 in Boston at PSX 2023. PSX is the Product Stewardship Society’s annual conference, and its website can be found here. Ms. Hantman serves on the Conference Planning Committee for PSX and looks forward to next year’s conference in Denver.
The presentation covered the incentives for the self-disclosure of violations provided by EPA’s audit policy, the conditions that must be met to qualify for audit policy penalty mitigation, and the benefits and risks of TSCA audits. Ms. Hantman discussed important considerations for companies conducting audits, such as compliance with the 21-day self-disclosure deadline and understanding the 5-year statute of limitations that applies to most TSCA violations. Ms. Hantman also highlighted the role of negotiations with EPA during an audit, for example, to avoid triggering penalties for repeat violations.
Particular attention was given to the New Owner Audit Policy, which allows new owners to get a clean baseline following the purchase of a facility. Ms. Hantman covered the additional benefits to new owners of conducting TSCA audits, which include the opportunity to seek indemnification from the seller for breach of reps and warranties, the opportunity to submit an insurance claim if the new owner purchased deal insurance, and further reduced economic penalties under the New Owner Audit Policy.
Also presenting was Ashish P. Deshmukh, PhD, Principal at Ramboll, who spoke about the particulars of audit processes and how product stewards can prepare for TSCA audits. The presentation was moderated by Robert DeMott, PhD, Principal Toxicologist at Ramboll.
If you have questions about the topics of the presentation, please contact Ms. Hantman.
EPA Finalizes TSCA Reporting and Recordkeeping Requirements for PFAS
/in EPA, PFAS, TSCAEPA has finalized its Toxic Substances Control Act (“TSCA”) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substance (“PFAS”) rule. The rule offers none of the customary TSCA reporting exemptions, such as the di minimus threshold exemption, article exemption, and research and development exemption. Although industry members voiced significant concerns over the proposed rule, the scope of the rule remains expansive. A summary of the final rule is detailed below.
Who does the final rule apply to?
40 CFR § 705.10 identifies the entities that are covered under the rule. The rule, which Congress mandated through the FY2020 National Defense Authorization Act, applies to all entities that have manufactured and/or imported a PFAS for commercial purposes, including those present in a mixture and in an article since January 1, 2011. Those who have only processed, distributed in commerce, used, and/or disposed of PFAS are not subject to this rule.
Which PFAS must be reported under the final rule?
EPA has identified PFAS subject to the rule by a structural definition rather than a list of substance identities (40 CFR § 705.5). However, EPA will provide a public list of substances that meet this definition on its CompTox Chemical Dashboard. The definition of PFAS using a structural definition is as follows:
This differs from the proposed rule, which defined PFAS as “a substance that includes the following structure: R-(CF2)–C(F)(R′)R″, in which both the CF2 and CF moieties are saturated carbons and none of the R groups (R, R′ or R″) can be hydrogen.”
Reporting threshold
There is no reporting threshold or de minimis level for PFAS reporting. The traditional TSCA reporting exemptions, such as byproducts and impurities, and low volume exemptions, are not being upheld under this rule and require reporting.
Reporting standard
40 CFR § 705.15 states that the reporting standard that applies to this rule is information “known or reasonably ascertainable” by the manufacturer. This means “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know” (See 40 CFR 704.3). Under this standard, the manufacturer must evaluate not only their current level of knowledge regarding substances that are manufactured or imported, including those in articles, but also any additional information that a reasonable person, similarly situated, would be expected to know, possess, or control.
To obtain the necessary information for reporting, EPA expects the manufacturer/importer to conduct a reasonable inquiry into their own organization and potentially make inquiries outside the organization. According to the Agency, this may require “phone calls or email inquiries to upstream suppliers or downstream users or employers or other agents of the manufacturer, including persons involved in the research and development, import or production, or marketing of the PFAS.”
If data is unknown or not reasonably ascertainable, the submitter should, if possible, submit reasonable estimates. If manufacturers or importers need additional information for reporting, but suppliers are unwilling to provide that information, they can send a request for information through EPA’s reporting tool.
What information must be reported?
The scope of information required is vast. Data elements are detailed at 40 CFR §705.15 and include:
Reporting on PFAS in Articles
Articles importers are subject to the reporting rule. The fact that there is no de minimis concentration threshold makes the scope of this mandate expansive. Because the known and reasonably ascertainable standard applies to this rule, importers must go beyond simply reviewing the SDSs for the imported articles. To demonstrate compliance with the rule, importers will need to survey their suppliers about the presence of PFAS in all of the articles they have imported since January 1, 2011. However, the rule does not mandate any product testing for article importers.
The rule does exempt some data elements from reporting for PFAS imported in articles, such as byproduct identification, worker exposure data, and disposal data.
R&D exemptions to the reporting requirements
Manufacturers and importers of R&D PFAS substances are subject to the reporting rule. The reporting requirements are reduced where volumes are below 10 kilograms annually.
Electronic reporting
All information must be submitted electronically through CDX (see 40 CFR § 705.35). A new tool, the Chemical Information Submission System (“CISS”), will be added to the CDX module “Submission for Chemical Safety and Pesticide Program” (“CSPP”). Reporting will be submitted through the CISS, which the Agency is currently developing, and will be live prior to the opening of the reporting period.
CBI claims
PFAS manufacturers reporting under this rule may claim CBI consistent with TSCA section 14, but they must make the CBI claim with their submission for this rule. CBI claims submitted for other reporting requirements will not be considered. See 40 CFR § 705.30 for details.
Reporting timeline
Manufacturers and importers will have one year from the effective date of this rule, November 13, 2023, to collect the data necessary for reporting and an additional six months to submit their reports; reports will be due May 13, 2023. Small manufacturers (as defined in 40 CFR 704.3) will have an additional six months to report, making their reporting deadline November 13, 2024.
Recordkeeping requirements
Manufacturers and importers subject to this rule must maintain records of all documents and information reported to EPA for five years, beginning on the last day of the information submission period.
GAO Releases Report on PFAS-Related Recommendations
/in GAO, PFASIn September 2023, the Government Accountability Office (GAO) released a three-page report detailing the recommendations it has previously made to government agencies for the purposes of “detecting, limiting exposure to, and treating PFAS contamination.”
GAO describes the following recommendations it made to EPA, FDA, and Department of Defense (DOD), respectively:
In addition to these recommendations, GAO stated that it is currently monitoring public water systems’ implementation of PFAS treatment methods. GAO also highlighted its July 2022 report on the technologies that could be used to address PFAS-related risks, which recommended that policymakers promote research, expand method development, and support full-scale PFAS treatment.
EPA Settles with Slack Chemical Company Following Alleged EPCRA Violations
/in Enforcement, EPA, EPCRA, Right-to-KnowOn October 11, 2023, EPA announced a settlement with Slack Chemical Company, Inc. (“Slack”) following alleged violations of the Emergency Planning and Community Right-to-Know Act (EPCRA) at two of the New York corporation’s facilities. The settlement includes a civil penalty of $231,300.
Under Section 313 of EPCRA, owners or operators of certain facilities are required to annually submit a Toxic Chemical Release Inventory Reporting Form R (“TRI Form R”) report for each chemical listed under 40 CFR 372.65 that was manufactured, processed or otherwise used in quantities exceeding a certain threshold. TRI Form R reports require information about on-site releases of the chemical into the environment, transfers of the chemical in waste to off-site locations, on-site waste treatment methods, and source reduction and recycling activities. Alternatively, owners or operators can opt to submit a simpler Toxic Chemical Release Inventory Reporting Form A (“TRI Form A”) report when the quantity of the chemical manufactured, processed, or otherwise used is one million pounds or less, the total quantity released, disposed, and treated at the facility is 500 pounds or less, and the chemical is not considered to be of special concern. TRI Form R/Form A reports are due no later than July 1 for the preceding calendar year.
EPA alleges that Slack, which describes itself as a “chemical warehousing, repackaging and distribution company,” failed to submit timely TRI Form R/Form A reports at its Carthage and Saratoga Springs facilities for calendar years 2019 and 2021. More specifically, EPA alleges that Slack:
In a news release, EPA stated that Slack has “voluntarily instituted a corporate compliance plan to prevent recurrence of EPCRA reporting violations,” which includes a written procedure listing the steps needed to identify TRI chemicals and their quantities.
Case Update: Motion to Dismiss Granted in PFAS Lawsuit Against L’Oreal
/in False Advertising, PFASIn March 2022, a class action lawsuit was filed against L’Oreal U.S.A., Inc. for alleged violations of state consumer protection laws related to the failure to disclose PFAS in their waterproof mascara products. The complaint alleged that L’Oreal violated numerous consumer protection laws, including New York General Business Laws 349 and 350, against fraudulent and misleading advertising by failing to disclose that its waterproof mascara products contain PFAS. (Verdant Law published a detailed blog post on the litigation, which can be found here.)
In a recent ruling on September 30, 2023, the U.S. District Court for the Southern District of New York granted L’Oreal’s motion to dismiss the case. The court concluded that the plaintiffs failed to demonstrate standing, as they didn’t sufficiently prove that the specific mascaras they purchased contained PFAS.
The plaintiffs based their claims on a 2021 University of Notre Dame study that found high fluorine levels in various cosmetic products, including waterproof mascaras, commonly advertised as long-lasting or wear-resistant. Plaintiffs did not allege or provide any evidence that the Notre Dame study had included a review of any L’Oreal products.
The plaintiffs also conducted their own study, alleging that the L’Oreal mascaras tested had PFAS levels above the EPA’s lifetime Health Advisory Level (the health advisory level is the amount of PFAS that is most certain not to cause harmful human effects if consumed over a lifetime). Nonetheless, the court found these allegations lacking in specific details, such has how many samples were tested and if all samples tested were positive for PFAS. Nor, according to the court, did the study link the findings to the actual products purchased by the plaintiffs. The court dismissed the case without prejudice and with leave to amend.
California Governor Vetoes Three Bills Restricting PFAS in Consumer Products
/in California, PFASOn October 8, 2023, California Governor Gavin Newsom announced that he had vetoed three bills passed by California’s state legislature designed to restrict PFAS in certain consumer products. The three bills vetoed by Newsom are as follows:
In his veto messages for each of the three bills, Newsom provided an identical rationale for his decision. Newsom wrote that he “strongly support[s] the author’s intent and [has] signed similar legislation in the past” but is concerned that the bill does not identify a regulatory agency to determine or enforce compliance with the proposed statute. According to Newsom, similar legislation that has been enacted without regulatory oversight has been challenging to implement due to inconsistent interpretations and confusion among manufacturers on how to comply. Newsom concluded each message by stating that he is directing the Department of Toxic Substances Control to work with the bill’s author and the legislature to consider other approaches to PFAS regulation.